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FDA Enforcement of 21 CFR 11 Compliance
- 21 CFR 11 then and now: a brief history of 21 CFR 11 and what it looks like today
- Part 11 Basics
- FDA’s view of 21 CFR 11 Compliance
-FDA Acceptance of Data: Electronic & Paper
-Computerized systems and eData
-The basis for Part 11 Compliance and purpose of protection and validation
-Diverse nature of “source” and how to protect and preserve it
-Purpose and goal of 21 CFR 11 BIMO inspection
-Inspection of electronic records - BIMO
- The 10 Deadly Sins that break compliance
- Examples of 21 CFR 11 Citations
- How to prepare your company for successful Part 11 inspections
Overview of the webinar
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations.
Citations are related to inadequate data integrity, security and availability of electronic records but also related to validation of software and computer systems. However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what the FDA is looking for in these inspections.
Who should attend?
- VP of IT
- Director of IT
- Quality Managers
- Project Managers (for CSV / IT)
- Validation Specialists
- Database Administrators
- System Administrators
- Directors / Senior Directors of Discovery
- Directors / Senior Directors of Development
- Directors / Senior Directors of Commercialization
- Document Managers
- Training Managers
- Doctors
- Nurses
- Clinical Data Managers and Monitors
- IRB
- FDA Investigators
- Part 11 and Annex 11 Consultants
- Medical consultants
Why should you attend?
This webinar will ensure that attendees are able to do the following:
- Understand what 21 CFR 11 means, why and how it was implemented
- Understand FDA’s view of what is enforced in Part 11 inspections
- Understand how to prepare your company for Part 11 inspections
Faculty - Mz.Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.